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Timing of Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus (HIV)—Associated Tuberculous Meningitis

Clinical infectious diseases, 2011-06, Vol.52 (11), p.1374-1383 [Peer Reviewed Journal]

Copyright © 2011 Oxford University Press on behalf of the Infectious Diseases Society of America ;Crown copyright 2011. 2011 ;2015 INIST-CNRS ;Copyright University of Chicago, acting through its Press Jun 1, 2011 ;ISSN: 1058-4838 ;EISSN: 1537-6591 ;DOI: 10.1093/cid/cir230 ;PMID: 21596680 ;CODEN: CIDIEL

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Title:
Timing of Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus (HIV)—Associated Tuberculous Meningitis
Author: Török, M. Estee ; Yen, Nguyen Thi Bich ; Chau, Tran Thi Hong ; Mai, Nguyen Thi Hoang ; Phu, Nguyen Hoan ; Mai, Pham Phuong ; Dung, Nguyen Thi ; Van Vinh Chau, Nguyen ; Bang, Nguyen Duc ; Tien, Nguyen Anh ; Minh, N. H. ; Hien, Nguyen Quang ; Thai, Phan Vuong Khac ; Dong, Doan The ; Anh, Do Thi Tuong ; Thoa, Nguyen Thi Cam ; Hai, Nguyen Ngoc ; Lan, Nguyen Ngoc ; Lan, Nguyen Thi Ngoc ; Quy, Hoang Thi ; Dung, Nguyen Huy ; Hien, Tran Tinh ; Chinh, Nguyen Tran ; Simmons, Cameron Paul ; Jong, Menno de ; Wolbers, Marcel ; Farrar, Jeremy James
Subjects: Adult ; AIDS ; Anti-HIV Agents - administration & dosage ; Anti-HIV Agents - adverse effects ; Anti-Inflammatory Agents - administration & dosage ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiretroviral drugs ; Antiretroviral Therapy, Highly Active - adverse effects ; Antiretroviral Therapy, Highly Active - methods ; Antiretrovirals ; Antitubercular Agents - administration & dosage ; Antiviral agents ; Art therapy ; Arts ; Bacterial diseases ; Bacterial diseases of the nervous system. Bacterial myositis ; Benzoxazines - administration & dosage ; Biological and medical sciences ; Clinical trials ; Dexamethasone - administration & dosage ; Double-Blind Method ; Female ; HIV ; HIV 1 ; HIV Infections - complications ; HIV Infections - drug therapy ; HIV Infections - mortality ; HIV/AIDS ; Human bacterial diseases ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Infectious diseases ; Lamivudine - administration & dosage ; Male ; Medical sciences ; Medical treatment ; Meningeal tuberculosis ; Meningitis ; Mortality ; Pharmacology. Drug treatments ; Placebos - administration & dosage ; Random allocation ; Risk assessment ; Statistical median ; Time Factors ; Treatment Outcome ; Trimethoprim, Sulfamethoxazole Drug Combination - administration & dosage ; Tuberculosis, Meningeal - complications ; Tuberculosis, Meningeal - drug therapy ; Tuberculosis, Meningeal - mortality ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids ; Zidovudine - administration & dosage
Is Part Of: Clinical infectious diseases, 2011-06, Vol.52 (11), p.1374-1383
Description: Background. The optimal time to initiate antiretroviral therapy (ART) in human immunodeficiency virus (HIV)—associated tuberculous meningitis is unknown. Methods. We conducted a randomized, double-blind, placebo-controlled trial of immediate versus deferred ART in patients with HIV-associated tuberculous meningitis to determine whether immediate ART reduced the risk of death. Antiretroviral drugs (zidovudine, lamivudine, and efavirenz) were started either at study entry or 2 months after randomization. All patients were treated with standard antituberculosis treatment, adjunctive dexamethasone, and prophylactic co-trimoxazole and were followed up for 12 months. We conducted intention-to-treat, perprotocol, and prespecified subgroup analyses. Results. A total of 253 patients were randomized, 127 in the immediate ART group and 126 in the deferred ART group; 76 and 70 patients died within 9 months in the immediate and deferred ART groups, respectively. Immediate ART was not significantly associated with 9-month mortality (hazard ratio [HR], 1.12; 95% confidence interval [CI],.81-1.55; P = .50) or the time to new AIDS events or death (HR, 1.16; 95% CI,.87-1.55; P = .31). The percentage of patients with severe (grade 3 or 4) adverse events was high in both arms (90% in the immediate ART group and 89% in the deferred ART group; P = .84), but there were significantly more grade 4 adverse events in the immediate ART arm (102 in the immediate ART group vs 87 in the deferred ART group; P = .04). Conclusions. Immediate ART initiation does not improve outcome in patients presenting with HIV-associated tuberculous meningitis. There were significantly more grade 4 adverse events in the immediate ART arm, supporting delayed initiation of ART in HIV-associated tuberculous meningitis.
Publisher: Oxford: Oxford University Press
Language: English
Identifier: ISSN: 1058-4838
EISSN: 1537-6591
DOI: 10.1093/cid/cir230
PMID: 21596680
CODEN: CIDIEL
Source: MEDLINE
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Timing of Initiation of Antiretroviral Therapy in Human Immunodeficiency Virus (HIV)—Associated Tuberculous Meningitis

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